# K993436: Cavermap Surgical Aid

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: Feb 11, 2000 after 122 days
- Product code: FGM (Probe And Director, Gastro-Urology)
- Device class: 1
- Regulation: 21 CFR 876.4730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844216 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970971: Uro Med Nerve Stimulator, Uromed Corp. (1997) Summary page 1.

## Most influential descendants
- K200886: StimSite (2020), 0 descendants of its own

## Recalls of this device
- Jul 10, 2003 · Not classified · Z-1235-03: Product's sterility is compromised due to a failed sterility audit

## Indications for use
The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon’s expertise in mapping out the neurovascular bundles. Each surgeon’s skill determines whether these nerves are spared regardless of any aid.

Source page: https://510kreport.com/device/K993436
Methodology: https://510kreport.com/methodology